NCT01521455

Brief Summary

The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Feb 2012

Typical duration for phase_1 asthma

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

January 26, 2012

Last Update Submit

August 22, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • mean change of morning predose FEV1 from baseline

    day 14

Study Arms (2)

HCP0910

EXPERIMENTAL

Fluticasone /salmeterol 250/50 combination capsule

Drug: HCP0910

Seretide Diskus

ACTIVE COMPARATOR

Seretide 250 Diskus

Drug: Seretide Diskus

Interventions

HCP0910DRUG

250/50, BID for 2 weeks

HCP0910
Seretide DiskusDRUG

250/50, BID for 2 weeks

Seretide Diskus

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20 \~ 75 inclusive
  • Asthmatic diagnosis in more than 12 weeks from screening day
  • Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2

You may not qualify if:

  • Maintain controlled asthma for more than 4 weeks before screening
  • Diagnosed as a severe asthmatic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyunggi -do, South Korea

Location

Ajou University Hospital

Suwon, Gyunggi -do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Ewha Womans University Medical Center

Seoul, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Samsung medical center

Seoul, South Korea

Location

Seoul National University

Seoul, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Kyung-mi Park, Ph.D

    Hanmi Pharmaceutical Co.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 30, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations

KR(7)